Joseph Lee

About Joseph Lee

I am a scientific executive with 20+ years of experience leading analytical development, CMC strategy, and regulatory submissions across biologics, gene therapy, and vaccines. Throughout my career, I have built and scaled high-performing teams, shaped global analytical control strategies, and driven IND, BLA, and MAA approvals.My expertise spans viral vector platforms (AAV, Lentivirus, CAR-T, TCR-T, RNA/DNA), analytical development, regulatory compliance (FDA, EMA, ICH), and partnership management with CROs/CDMOs. I bring a proven ability to integrate science, business, and regulatory insight—aligning analytical innovation with organizational growth.Summary of Skills:• Leadership & Strategy: Global team leadership, organizational scale-up, succession planning, business development support• Analytical Development: Potency, purity, identity, safety assays; analytical control strategy; lifecycle management; Phase-appropriate method validation and implementation • CMC & Regulatory Expertise: IND, BLA, MAA submissions; regulatory strategy; compliance with FDA, EMA, ICH guidelines• External Partnerships: CRO/CDMO management, contract negotiation, technology transfer• Innovation & Operations: Automation, digital integration, informatics, due diligence, M&A supportProject and Technical/Scientific Skills Include:• Experienced in regulatory compliance (R&D, GCP/GLP, cGMP) within FDA, EMA, ICH, and WHO guidelines• SME for QA/Regulatory support, including Module 3 authorship• Expertise in assay/method development (purity, identity, safety, potency) from development through validation (ICH Q2)- protein biochemistry, molecular biology, cell biology, and immunological assays (flow cytometry, ELISA, IHC).• Analytical Technology Transfers, Root Cause Investigations (AE, OOS, deviations), CAPA, and Continuous Improvement initiatives (Life Cycle Management)• Program support for biologics, vaccines, and gene/cell therapy platforms (Autologous/Allogenic CAR-T, TCR-) and Viral/Non-viral Delivery (Lenti, Retro, AdV, AAV, mRNA/DNA, genome editing)• Viral vector design, production, purification, and analysis (AAV, Adeno, Retro, Lenti)

Experience

1. Senior Director, Integrated Attribute Sciences

   Bristol Myers Squibb

   Aug 2024 — Present · Warren, NJ, US

   Key Responsibilities• Led and managed the Attribute Sciences (Product Sciences) group supporting BMS T-cell therapy pipeline• Defined overall strategy and drove the discovery and application of quality attributes to inform the integrated control strategy; developed biological hypothesis driven studies to characterize cellular and viral attributes, and correlation to clinical outcomes• Built cross-functional collaboration to develop complex characterization strategies relating to clinical and non-clinical product development• Directed the development of robust, sensitive, and fit-for-purpose bioanalytical assays to characterize cell and vector products, intermediates and starting material; directed assay method remediation and implementation (LCM)• Expanded framework to enable and enhance utilization and value capture of data via informatics-based correlative studies supporting knowledge building across the technical development portfolioKey Achievements• FY 2025 approved headcount: 25FTE/8 contract• Directed group authorship of appropriate sections (Module 3) including S.3.1 (Elucidation of Structure) and S.3.2 (Impurities)- multiple programs IND-IMPD approved• Conducted Analytical Control Strategy (identification of CQAs, routine and non-routine characterization panels) through implementation of Correlative Analysis (CMC; Translational, Clinical)• Managed involvement in program task forces for OOS and Adverse Event investigations (representing CMC)

Education

• McGill University

  Ph.D., Biochemistry

• Queen's University

  B.Sc., Life Sciences

Skills

• Tissue Culture
• Genetics
• Immunoprecipitation
• Cell Based Assays
• In Vitro
• Transfection
• Signal Transduction
• Fluorescence
• Cell
• Sds-Page
• Immunoassays
• Molecular Cloning
• Validation
• Cell Biology
• Immunohistochemistry
• Qpcr
• Microbiology
• Protein Purification
• High Throughput Screening
• Microscopy
• Biochemistry
• Drug Discovery
• Optimization
• Molecular Biology
• Immunology
• Assay Development
• Gene and Cell Therapy
• Flow Cytometry
• Target Identification
• Bacterial Transformation
• Cancer
• Mutagenesis
• Pcr
• Protein Chemistry
• Hts
• Cell Culture
• Life Sciences
• Lifesciences
• Purification
• Protein Expression